ASTM F 2504 : 2005

Name: ASTM F 2504 : 2005
Brand: ASTM
Price: 62.61 GBP

Superseded

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Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-11-2005

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Describes means for describing system performance (ex vivo) and, in particular, system output of an implantable middle ear hearing device (IMEHD) by measuring a physical quantity that is relevant to the insertion gain and output level of the IMEHD when implanted in the patient.

1.1 This practice defines means for describing system performance (ex vivo) and, in particular, system output of an implantable middle ear hearing device (IMEHD) by measuring a physical quantity that is relevant to the insertion gain and output level of the IMEHD when implanted in the patient.

1.2 This practice is similar to headphone calibration on an artificial ear in which the sound pressure level (in decibel sound pressure level (SPL)) measured in the artificial ear can be converted to patient hearing level (in decibel hearing level (HL)) using a known transfer function, as defined by ANSI 3.7. These measurements can then be used to predict system parameters relevant for patient benefit such as functional gain, maximum output, and variability. Measurements defined in this practice should be useful for patients, clinicians, manufacturers, investigators, and regulatory agencies in making comparative evaluations of IMEHDs.

1.3 The values given in SI units are to be considered the standard.

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Committee	F 04
DocumentType	Standard Practice
Pages	6
ProductNote	Reconfirmed 2005
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 2504 : 2005 : R2014

ANSI/ASA S3.7 : 2016	METHOD FOR MEASUREMENT AND CALIBRATION OF EARPHONES
ANSI S3.6 : 2010	SPECIFICATION FOR AUDIOMETERS
ANSI/ASA S3.22:2014	SPECIFICATION OF HEARING AID CHARACTERISTICS